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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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Coordinate with the Director of Federal Regulatory Affairs, the VP of US Policy and Regulatory Strategy, Corporate Affairs, and the NY and MA Regulatory and Pricing teams and the NGV (National Grid Ventures) regulatory teams on externalization of National Grid transmission policy positions.
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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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This role functions in a matrix team environment, interacting with several key stakeholder groups including Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research, and Legal.
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These activities will be performed in cross-functional collaboration with a range of partners throughout the organization, including the US Market Access, US Medical Affairs, Medical Outcomes Science Liaison (MOSL), Public Policy & Government Relations, and US Regulatory Affairs teams.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Reporting to the Chief of Communications and Public Affairs, the Senior Director of Events will oversee the strategic planning and timely execution of events that reflect our new, community-centric strategic direction and contribute to our vision of advancing a region where access to financial well being is universal and prosperity is shared across race and ethnicity, and provide and special experiences for target audiences and affiliated marketing components.
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Focus on financial organizations that address SEC, CFTC, FINRA, NFA OCC and other regulatory requirements for retail and institutional broker-dealer, capital markets, banking, swap dealer trading, investment management, and investment advisor compliance.
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Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents.
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Works closely and builds effective working relationships with accreditation and regulatory agencies, i.e., The Joint Commission, DPH, DMH and CMS. Responsible for all aspects of the plan to ensure continual readiness with the clinical regulatory and accreditation requirements of the TJC, DPH, DMH and CMS.
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The Director of Medical Affairs at Thermo Fisher Scientific will play a pivotal role in both strategically and functionally leading the North American (NA) Medical Affairs Team, undertaking the initiatives supporting the Clinical Sequencing Division (CSD) activities.
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Under the direction and guidance of the Associate Vice President, Career and Digital Strategy, the Senior Director of Industry and Employer Engagement will develop and lead the implementation of a comprehensive strategic plan that drives engagement with industry, including employers, recruiters and alumni in coordination with Academic Affairs, the International Career Center (ICC) and Alumni Affairs.
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regulatory affairs jobs Title: assistant Company: Healthpro in Cambridge, MA
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